New treatment for acne scars?
NEW YORK (Reuters) - Medicis Pharmaceutical Corp. said Friday it won
U.S. approval to sell an injectable gel for temporarily filling
facial wrinkles.
The injection is made from hyaluronic acid, a complex sugar found in
all living organisms.
Medicis’ treatment, called Restylane, is approved in more than 60
countries and is manufactured by Sweden’s Q-Med AB.
An FDA (news - web sites) spokeswoman said the agency has not yet
taken action on a competing product, called Hylaform, under
development by Inamed Corp. and Genzyme . Hylaform has been on the
market in Europe since 1996 and is sold in 30 countries.
Two other injectable products for treating wrinkles include collagen
injections for correcting soft tissue deficiencies and acne scars
and Botox for treating frown lines between the eyebrows, FDA said in
a statement.
Restylane’s results in treating wrinkles around the nose and mouth
are seen immediately after treatment and last six months or longer,
Medicis said.
Medicis claims that Restylane requires less material to achieve its
desired volume than collagen and requires fewer treatment sessions.
Restylane is formulated as a clear gel and integrates into skin
tissue and then attracts and binds to water molecules to maintain
volume, Medicis said.
Side effects included redness and swelling, typically at the
injection site. The FDA said incidents of swelling, bruising, pain
and tenderness were lower with follow up injections.
Q-Med has agreed to conduct a post-approval study in people of color
to determine the product’s safety for this population, since there
was limited data in the study on non-caucasians, the FDA said.